Table 3.
Most Common Treatment‐Related Adverse Events Reported in ≥10% of Patients
| Adverse Event | Dose | Overall (N = 28) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7.5 mg (n = 1) | 15 mg (n = 2) | 30 mg (n = 9) | 45 mg (n = 9) | 60 mg (n = 7) | ||||||||
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Fatigue | 1 (100) | 0 | 1 (50) | 0 | 4 (44) | 0 | 5 (56) | 1 (11) | 7 (100) | 1 (14) | 18 (64) | 2 (7) |
| Nausea | 1 (100) | 0 | 0 | 0 | 4 (44) | 0 | 6 (67) | 0 | 3 (43) | 0 | 14 (50) | 0 |
| Diarrhea | 0 | 0 | 1 (50) | 0 | 3 (33) | 0 | 4 (44) | 0 | 5 (71) | 1 (14) | 13 (46) | 1 (4) |
| Hyperglycemia | 0 | 0 | 0 | 0 | 4 (44) | 2 (22) | 4 (44) | 1 (11) | 4 (57) | 2 (29) | 12 (43) | 5 (18) |
| Mucositis | 0 | 0 | 1 (50) | 0 | 2 (22) | 0 | 3 (33) | 0 | 5 (71) | 2 (29) | 11 (39) | 2 (7) |
| Decreased appetite | 0 | 0 | 0 | 0 | 4 (44) | 0 | 3 (33) | 0 | 2 (29) | 0 | 9 (32) | 0 |
| Vomiting | 0 | 0 | 0 | 0 | 2 (22) | 0 | 2 (22) | 0 | 5 (71) | 0 | 9 (32) | 0 |
| Asthenia | 0 | 0 | 1 (50) | 0 | 2 (22) | 0 | 1 (11) | 0 | 3 (43) | 0 | 7 (25) | 0 |
| Rash | 0 | 0 | 1 (50) | 0 | 1 (11) | 0 | 2 (22) | 1 (11) | 3 (43) | 1 (14) | 7 (25) | 2 (7) |
| Dysgeusia | 1 (100) | 0 | 1 (50) | 0 | 0 | 0 | 2 (22) | 0 | 1 (14) | 0 | 5 (18) | 0 |
| Arthralgia | 0 | 0 | 0 | 0 | 0 | 0 | 2 (22) | 0 | 2 (29) | 1 (14) | 4 (14) | 1 (4) |
| Increased glycosylated hemoglobin | 0 | 0 | 0 | 0 | 0 | 0 | 2 (22) | 0 | 2 (29) | 0 | 4 (14) | 0 |
| Pruritus | 0 | 0 | 1 (50) | 0 | 1 (11) | 0 | 2 (22) | 0 | 0 | 0 | 4 (14) | 0 |
| Dry mouth | 0 | 0 | 0 | 0 | 1 (11) | 0 | 2 (22) | 0 | 0 | 0 | 3 (11) | 0 |
| Dyspnea | 0 | 0 | 0 | 0 | 1 (11) | 0 | 1 (11) | 0 | 1 (14) | 0 | 3 (11) | 0 |
| Rash pruritic | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 | 2 (29) | 2 (29) | 3 (11) | 2 (7) |
| Thrombocytopenia | 0 | 0 | 0 | 0 | 1 (11) | 0 | 2 (22) | 0 | 0 | 0 | 3 (11) | 0 |
Data are presented as n (%).